{
"info": {
"nct_id": "NCT00815620",
"official_title": "Best Therapy for Patients With Neuroendocrine Tumors",
"inclusion_criteria": "* Biopsy-proven neuroendocrine tumor (WHO class I-II, TNM grading 1-2)\n* Advanced disease with lymph node or distant metastases (N1, M1) undergoing cytoreduction by surgery/local ablative therapy or peptide receptor radiotherapy\n* curative intent of all therapies possible\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 90 Years",
"exclusion_criteria": "* Undifferentiated neuroendocrine carcinoma (WHO class III, TNM grading 3)\n* secondary tumor\n* advanced carcinoid heart disease requiring surgery",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Biopsy-proven neuroendocrine tumor (WHO class I-II, TNM grading 1-2)",
"criterions": [
{
"exact_snippets": "Biopsy-proven neuroendocrine tumor",
"criterion": "neuroendocrine tumor",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": "biopsy-proven"
}
]
},
{
"exact_snippets": "WHO class I-II",
"criterion": "WHO class",
"requirements": [
{
"requirement_type": "classification",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
]
},
{
"exact_snippets": "TNM grading 1-2",
"criterion": "TNM grading",
"requirements": [
{
"requirement_type": "grading",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
]
}
]
},
{
"line": "* Advanced disease with lymph node or distant metastases (N1, M1) undergoing cytoreduction by surgery/local ablative therapy or peptide receptor radiotherapy",
"criterions": [
{
"exact_snippets": "Advanced disease with lymph node or distant metastases (N1, M1)",
"criterion": "disease stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"N1",
"M1"
]
}
]
},
{
"exact_snippets": "undergoing cytoreduction by surgery/local ablative therapy",
"criterion": "cytoreduction treatment",
"requirements": [
{
"requirement_type": "treatment type",
"expected_value": [
"surgery",
"local ablative therapy"
]
}
]
},
{
"exact_snippets": "undergoing ... peptide receptor radiotherapy",
"criterion": "peptide receptor radiotherapy",
"requirements": [
{
"requirement_type": "treatment",
"expected_value": true
}
]
}
]
},
{
"line": "* curative intent of all therapies possible",
"criterions": [
{
"exact_snippets": "curative intent of all therapies possible",
"criterion": "therapies",
"requirements": [
{
"requirement_type": "intent",
"expected_value": "curative"
},
{
"requirement_type": "possibility",
"expected_value": true
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
},
{
"line": "Must have maximum age of 90 Years",
"criterions": [
{
"exact_snippets": "maximum age of 90 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 90,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Undifferentiated neuroendocrine carcinoma (WHO class III, TNM grading 3)",
"criterions": [
{
"exact_snippets": "Undifferentiated neuroendocrine carcinoma",
"criterion": "neuroendocrine carcinoma",
"requirements": [
{
"requirement_type": "differentiation",
"expected_value": "undifferentiated"
}
]
},
{
"exact_snippets": "WHO class III",
"criterion": "WHO classification",
"requirements": [
{
"requirement_type": "classification",
"expected_value": "III"
}
]
},
{
"exact_snippets": "TNM grading 3",
"criterion": "TNM grading",
"requirements": [
{
"requirement_type": "grading",
"expected_value": {
"operator": "=",
"value": 3,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* secondary tumor",
"criterions": [
{
"exact_snippets": "secondary tumor",
"criterion": "secondary tumor",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* advanced carcinoid heart disease requiring surgery",
"criterions": [
{
"exact_snippets": "advanced carcinoid heart disease",
"criterion": "carcinoid heart disease",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "advanced"
}
]
},
{
"exact_snippets": "requiring surgery",
"criterion": "surgery requirement",
"requirements": [
{
"requirement_type": "necessity",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}